510(k) K201867

Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System by Baxter Healthcare Corporation — Product Code FKX

K201867 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System". The FDA issued a decision of Substantially Equivalent on November 19, 2020. The device falls under product code FKX (System, Peritoneal, Automatic Delivery), a Class II device regulated under 21 CFR 876.5630. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.